PMA P970018S034

Device
BD TOTALYS SLIDEPREP
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S034
Product code
MKQ
Decision date
2016-06-17
Generic name
Processor, cervical cytology slide, automated
Approval order statement
Manufacturing site change.

Current openFDA PMA Record#

Device
BD TOTALYS SLIDEPREP
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S034
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2016-06-17
Decision code
OK30
Date received
2016-05-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing site change.